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A Study to Investigate Effects of Omega-3 Carboxylic Acids and Dapagliflozin on Liver Fat Content in Diabetic Patients (EFFECTII)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02279407
Recruitment Status : Completed
First Posted : October 31, 2014
Results First Posted : January 27, 2017
Last Update Posted : March 17, 2017
Sponsor:
Collaborator:
Uppsala Clinical Research, Uppsala, Sweden
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
This study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study performed in up to 5 centres in Sweden to assess the effect of Omega-3 carboxylic acids and dapagliflozin on liver fat in patients with Type 2 diabetes with fatty liver (>5.5% as measured with magnetic resonance imaging (MRI))

Condition or disease Intervention/treatment Phase
T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin) Drug: placebo Drug: Omega-3 carboxylic acids Drug: Dapagliflozin Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 223 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind Randomized Placebo-controlled, Parallel-group 12 Week Study to Investigate the Effects of Omega-3 Carboxylic Acids and Dapagliflozin on Liver Fat Content in Type 2 Diabetic Patients; EFFECT II
Study Start Date : January 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015


Arm Intervention/treatment
Placebo Comparator: placebo Drug: placebo
Placebo matching to Omega-3 carboxylic acids (olive oil)

Drug: Placebo
Placebo matching to dapagliflozin 10 mg

Experimental: Omega-3 carboxylic acids 4g / day Drug: Omega-3 carboxylic acids
4 g administered as 4 x 1 g capsules

Experimental: Dapagliflozin, 10mg / day Drug: Dapagliflozin
10 mg administered as 10 mg tablet

Experimental: Omega-3 carboxylic acids 4g/day+Dapagliflozin 10mg/day Drug: Omega-3 carboxylic acids
4 g administered as 4 x 1 g capsules

Drug: Dapagliflozin
10 mg administered as 10 mg tablet




Primary Outcome Measures :
  1. Change From Baseline to Week 12 in % Liver Fat as Assessed by MRI (Comparison Versus Placebo) [ Time Frame: 12 weeks ]
    To evaluate the efficacy of the combination therapy (Epanova + Dapagliflozin) when compared to placebo with respect to reduction in liver fat content (%) at the end of 12 weeks of double-blinded treatment. Treatment effect in liver fat reduction (%) was assessed using a mixed linear model with the change from baseline on logarithmic scale as response variable and the logarithm of the baseline value as covariate, treatment as fixed effect, and center as random effect. The treatment effect was then back-transformed to original scale as Geometric mean ratio and presented as percentage change from baseline.


Secondary Outcome Measures :
  1. Change From Baseline to Week 12 in % Liver Fat (Comparison Between Active Treatment Groups) [ Time Frame: 12 weeks ]
    To evaluate the relative efficacy of the combination of Epanova and dapagliflozin versus Epanova alone and dapagliflozin alone with respect to reduction in % liver fat at the end of 12 weeks of double-blind treatment. Treatment effect in liver fat reduction (%) was assessed using a mixed linear model with the change from baseline on logarithmic scale as response variable and the logarithm of the baseline value as covariate, treatment as fixed effect, and center as random effect. The treatment effect was then back-transformed to original scale as Geometric mean ratio and presented as percentage change from baseline.



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Provision of informed consent prior to any study specific procedures; Men or women ≥40 years and ≤75 years with suitable veins for cannulation or repeated venepuncture; Have liver fat content as assessed by MRI >5.5%; Diagnosis of Type 2 diabetes since at least 6 months in accordance with WHO criteria.

Exclusion Criteria: Any condition when MRI is contraindicated such as, but not limited to, having a pacemaker or claustrophobia; Diagnosis or signs of Type 1 diabetes (e.g. history of positive islet antibodies); Creatinine clearance <60 mL/min at screening (Cockcroft-Gault formula).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279407


Locations
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Sweden
Research Site
Göteborg, Sweden
Research Site
Linkoping, Sweden
Research Site
Stockholm, Sweden
Research Site
Uppsala, Sweden
Research Site
Örebro, Sweden
Sponsors and Collaborators
AstraZeneca
Uppsala Clinical Research, Uppsala, Sweden
Investigators
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Principal Investigator: Jan Eriksson, MD Uppsala University Hospital, Uppsala, SE

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02279407    
Other Study ID Numbers: D5883C00004
First Posted: October 31, 2014    Key Record Dates
Results First Posted: January 27, 2017
Last Update Posted: March 17, 2017
Last Verified: February 2017
Keywords provided by AstraZeneca:
omega-3 carboxylic acid
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Digestive System Diseases
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs